Global pharma major Lupin on Friday said it has received approval from the US health regulator for phytonadione injectable emulsion USP, used for treating low blood clotting and bleeding disorders caused by vitamin K deficiency.
“The United States Food and Drug Administration (USFDA) has approved Lupin’s phytonadione injectable emulsion USP, 1 mg/0.5 mL single-dose prefilled syringe as bioequivalent to the reference listed drug, phytonadione injectable emulsion, 1 mg/0.5 mL, of International Medication Systems Ltd,” Lupin said in a regulatory filing.
According to IQVIA MAT August 2026, the company’s Abbreviated New Drug Application (ANDA) phytonadione injectable emulsion, which is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K deficiency, had estimated annual sales of USD 52.3 million in the US, the filing added.
Published on October 9, 2026
